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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discriminator, Two-Point
510(k) Number K944234
Device Name TCD OR TCD NEUROPATHY STAR
Applicant
JCM MANAGEMENT & PLANNING CO.
117 PARRISH LN.
WILMINGTON,  DE  19810
Applicant Contact CHARLES LAUDADIO
Correspondent
JCM MANAGEMENT & PLANNING CO.
117 PARRISH LN.
WILMINGTON,  DE  19810
Correspondent Contact CHARLES LAUDADIO
Regulation Number882.1200
Classification Product Code
GWI  
Date Received08/31/1994
Decision Date 03/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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